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December 15, 2015
Millennium Collaborative Care PPS
Erie County Medical Center
Greg Turner, DSRIP Director
Millennium Collaborative Care
462 Grider Street
Buffalo, New York 14215
Dear Mr. Turner:
The New York State Department of Health (DOH), the Office of Mental Health (OMH),
and the Office of Alcoholism and Substance Abuse Services (OASAS) are pleased to respond
to the request for waivers from certain regulatory requirements submitted under the Delivery
System Reform Incentive Payment (DSRIP) Program. This letter responds to the request
submitted by Erie County Medical Center, in its capacity as lead for the Millennium Collaborative
Care Performing Provider System (PPS).
Pursuant to Public Health Law (PHL) 2807(20)(e) and (21)(e), and in connection with
DSRIP Project Plans and projects under the Capital Restructuring Financing Program which are
associated with DSRIP projects, the Department, OMH, and OASAS may waive regulations for
the purpose of allowing applicants to avoid duplication of requirements and to allow the efficient
implementation of the proposed projects. However, the agencies may not waive regulations
pertaining to patient safety nor waive regulations if such waiver would risk patient safety.
Further, any waivers approved under this authority may not exceed the life of the project or such
shorter time periods as the authorizing commissioner may determine.
Accordingly, any regulatory waivers approved herein are for projects and activities as
described in the Project Plan application and any implementation activities reasonably
associated therewith. Such regulatory waivers may no longer apply should there be any
changes in the nature of a project. It is the responsibility of the PPS and the providers that have
received waivers to notify the relevant agency when they become aware of any material change
in the specified project that goes beyond the scope of which the waiver was granted. Further,
any regulatory waivers approved are only for the duration of the projects for which they were
requested.
The approval of regulatory waivers are contingent upon the satisfaction of certain
conditions. In all cases, providers must be in good standing with the relevant agency or
agencies. Other conditions may be applicable, as set forth in greater detail below. The failure
to satisfy any such conditions may result in the withdrawal of the approval, meaning that the
providers will be required to maintain compliance with the regulatory requirements at issue and
could be subject to enforcement absent such compliance.
1
Specific requests for regulatory waivers included in the Millennium Collaborative Care
PPS Project Plan application are addressed below.
1
Millennium Collaborative Care
709.3
2.a.i.; 2.b.vii.; 3.a.i.
Background and Justification submitted with your request:
In order to further integrate UAHS (by merging Olean General Hospital and Bradford
Regional MC), the Sub Acute Rehab program needs to be continued (has $650K margin).
The average daily census of a merged entity would exceed the 100 limit for swing beds.
Converting the swing beds to SNF beds addresses the issue as LTC beds are not counted in
average daily census. The further integration of UAHS will have a $1.5M impact on the system,
clearly having a stabilizing effect on OGH. The further integration will also assist OGH in
projects noted herein.
Response to Waiver Request:
No waiver needed. There is no regulatory limit on a hospital's swing bed capacity. If
the PPS wishes to change the designation of 20 hospital swing beds to nursing home beds,
hospital regulations and reimbursement would no longer apply to these beds. Nursing home
regulations and reimbursement apply. Bed need methodology aside, the PPS may find that the
cost of complying with nursing home requirements (i.e. renovations and space requirements) is
too high to be cost effective. The change in reimbursement might also erode some of the
current profit margin derived from the swing beds.
2
Millennium Collaborative Care
10 NYCRR 83
3 fi, 4 di
Background and Justification submitted with your request:
Both organizations already have a good working relationship but realize that the best
case scenario would be to co-locate. By doing so both organizations would increase their staff’s
knowledge, encourage further collaboration, decrease overall costs and expand service
provision. Additionally, consumers, and human service agencies, would know where to go for
the critical services these programs provide to new moms and children.
Response to Waiver Request:
Determination pending. The potential for permitting providers to share the same
licensed physical space is under review.
3
Millennium Collaborative Care
Sections 2962, 2970, 2971 of PBH Law
2bvii
Background and Justification submitted with your request:
1. Current regulation requires a Physician to sign off on MOLST. This can cause a
delay in MOLST activation or providers to be out of compliant. There also exists
varying time frames of recertification depending on the patient's setting, such as
review every seven days in an acute setting. We request that NPs and Pas be
2 allowed to sign these orders so that providers and facilities more easily maintain
compliance, and patient orders be activated more timely.
2. Nurse Practitioners and Physician Assistants already engage patients and
healthcare decision makers in end-of-life care discussions
3. NPs and PAs receive training that prepares them to have discussions on the kinds of
medical interventions that are discussed on the MOLST form and what those
interventions would do for the patient
4. Sometimes there is a delay in the MOLST process because the form must be signed
by both the patient/decision maker and the physician but the physician isn’t on site to
validate the form
5. Allowing NPs and PAs to sign the MOLST form to create immediately actionable
orders will help to encourage discussion of end-of-life treatment options and raise
awareness of the availability of MOLST
6. Allowing NPs and PAs to sign the MOLST form would ensure patient's end-of-life
care preferences are honored by eliminating any delays.
Response to Waiver Request:
Denied. We do not have the authority to waive state statute.
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Millennium Collaborative Care
Section 2802-a of PHL amended by Chapter 58
authorizing Commissioner to approve TCUs
2bvii
Background and Justification submitted with your request:
1. Allow Ventilator beds in Transitional Care unit allowing for an average length of stay
greater than 20 days. CON would be necessary for the transition of standard TCU
beds to ventilator beds. The currently is a great shortage of post-acute ventilator
beds in Western New York, with patients being transferred to Pennsylvania and NYC
as a result. The addition of these beds would allow us to care for the residents of
WNY in their community.
2. Allow TCU to receive Medicaid reimbursement. Currently TCU's cannot receive
Medicaid reimbursement. This would limit the patients who may require the higher
acuity care that can be provided on a TCU increasing acute LOS or readmissions
from SNFs.
3. Allow transfers from other PPS hospitals. Currently the TCU must accept patients
from its own hospital where it is located. If these ventilator beds are located in the
TCU, it would fill the need from the community and entire PPS. We ask that this
waiver not be limited to ventilator beds and allow all TCU beds to accept transfers.
4. Allow an average Length of stay greater than 20 days for ventilator beds. The
patients would be located within the hospital in the TCU, which would allow a
lengthened weaning potential in the safest environment.
Response to Waiver Request:
Denied. We do not have the authority to waive state statute.
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Millennium Collaborative Care
NYCRR Subpart 67-13
2(b)vii
3 Background and Justification submitted with your request:
Request the use of an EPOC Electronic Point of Care Technology to obtain Blood
Chemistry and Hematology within minutes. Requesting that this be added as a CLIA waived
service enabling on-the-spot assessment without having to send patients to the E.R. or Hospital
for Assessment and appropriate treatment. Obtain “instant” results for specific blood chemistry
and hematology to be immediately incorporated into decision to transfer patient to the hospital
or treat in place in the SNF.
Response to Waiver Request:
Denied. We do not have the authority to waive state statute.
6
Millennium Collaborative Care
10 NYCRR 83
3 fi and 4 di
Background and Justification submitted with your request:
Expansion of obstetrics and reduce low birth rates. Colocation allows for us to operate a
site in the same space as the county. Both clinics will operate separate EHRs.
Response to Waiver Request:
Determination pending. The potential for permitting providers to share the same
licensed physical space is under review.
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Millennium Collaborative Care
NYCRR (703.6)
3 fi and 4 di
10 NYCRR 401.1, 10 NYCCR 700.2 (a)(22) and 10
Background and Justification submitted with your request:
Expansion of obstetrics and reduce low birth rates. Colocation allows for us to operate a
site in the same space as the county. Both clinics will operate separate EHRs.
Response to Waiver Request:
Determination pending. The potential for permitting providers to share the same
licensed physical space is under review.
8
Millennium Collaborative Care
14 NYCRR 599.4 (r) and (ab)
3 fi and 4 di
Background and Justification submitted with your request:
Expansion of obstetrics and reduce low birth rates. Colocation allows for us to operate a
site in the same space as the county. Both clinics will operate separate EHRs.
Response to Waiver Request:
4 Determination pending. The potential for permitting providers to share the same
licensed physical space is under review.
9
Millennium Collaborative Care
14 NYCRR 599.4 (r) and (ab)
3 ai
Background and Justification submitted with your request:
Restriction easement on threshold visits allows us to perform services at same time for
patient convenience.
Response to waiver Request:
Integrated Services. Approved solely with respect to 14 NYCRR 599.4(r) and (ab ),
which will be waived contingent upon following the DSRIP Project 3.a.i Licensure Threshold
Model, outlined in Appendix A to this letter. However, the Department, OMH and OASAS do not
believe any additional waivers are needed if providers are integrating services under such a
model. As noted in Appendix A, the use of this model is contingent upon, among other things:
submission of an application by the PPS, with the identification all providers involved in such
model; the verification of the good standing of such providers by the Department, OMH and
OASAS, as appropriate; and satisfaction of the physical plant standards as delineated in
Appendix A.
If a PPS later identifies the need for a waiver, a request can be made at that time.
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Millennium Collaborative Care
Title X: Section 709.8 (b)(4 2.a.i
Background and Justification submitted with your request:
Granting this waiver to reduce the required number of pediatric BMT beds to 2, would
allow WCHOB to secure licensed pediatric BMT beds in the Oishei Children’s Hospital to
optimize delivery of care, keeping patients closer to home and avoiding costly travel or sending
patients out of state for services through our collaboration with Roswell Park Cancer Institute. A
pediatric BMT program is an essential component of a comprehensive pediatric
hematology/oncology program.
Response to waiver Request:
Approved. BMT Beds.
11
Millennium Collaborative Care
Title X: Section 405.30 (b) (3)
2.a.i
Background and Justification submitted with your request:
When fully operational, to ensure quality of care, the hospital shall perform at least 10
liver transplants per year if it is to continue as an approved liver transplant program; or at least
10 human heart transplants per year if it is to continue as an approved heart transplant program;
or at least 10 kidney transplants a year if it is to continue as an approved kidney transplant
program; or at least 10 lung transplants per year if it is to continue as an approved lung
5 transplant program. The Department will monitor outcomes for graft and patient survival.
Granting this waiver to reduce the number of pediatric kidney transplants, would allow WCHOB
to optimize delivery of pediatric kidney transplant care for our community, as the only stand­
alone Children's Hospital allowing us to treat patients closer to home, avoiding costly travel or
sending patients out of state for services, through collaboration with Erie County Medical
Center.
Response to waiver Request:
More Information needed. The Department cannot waive the CON requirement for full
review of a pediatric transplant program. However, we would consider waiving the
programmatic minimum volume requirement in an approved pediatric transplant program.
12
Millennium Collaborative Care
6738 Ciii (iii)
2.b.viii
NYS Physical Therapy: Rules & Regulations:
Background and Justification submitted with your request:
6738 Ciii (iii) states that periodic treatment and evaluation of the patient by the
supervising licensed physical therapist, as indicated in the plan of care and as determined in
accordance with patient need, but in no instance shall the interval between such treatment
exceed every six patient visits or thirty days, whichever occurs first; The PPS requests to strike
every 6 visits from the language. Utilization of licensed physical therapists are a valuable
resource in home health care, carrying out physical therapy treatments under the supervision of
a licensed physical therapist. Many if not most state regulations call for on-site supervision of
PTAs every 12 visits or 30 days. The 6 day supervision requirement greatly restricts the ability
of PTs and PTAs to optimize the efficiency of carrying out these highly effective treatments.
Physical Therapists are difficult to recruit, particularly in rural counties and by easing the
supervision requirements it would insure that all patients are able to receive the full therapeutic
benefit of their services.
Response to Waiver Request:
Denied. This requirement is in New York State Education law and we do not have the
authority to waive statute.
13
Millennium Collaborative Care
Title: 10, Section 763.5a
2.b.viii
Background and Justification submitted with your request:
The regulation states the initial patient visit shall be made within 24 hours of receipt and
acceptance of a community referral or return home from institutional placement. The PPS
requests this be changed to 48 hours. To have a consistent expectation that follows the Federal
guideline of 48 hours. This will allow the agency the ability to prioritize care based on patient
condition verses referral date within the first 48 hours.
Response to Waiver Request:
6 Approved. Federal regulation CFR 484.55 allows for an initial assessment visit by an
R.N. or appropriate therapist (if a therapy-only case) within 48 hours of referral, inpatient
discharge or on the physician ordered start of care date.
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Millennium Collaborative Care
Title: 10 Section: 763.4 h 6
2.b.viii
Background and Justification submitted with your request:
The regulation states that supervision of a home health aide or personal care aide is
conducted by a registered professional nurse or licensed practical nurse or by a therapist if the
aide carries out simple procedures as an extension of physical therapy, occupational therapy or
speech/language pathology. The PPS requests the removal of "if the aide carries out simple
procedures as an extension of physical therapy, occupational therapy or speech/language
pathology.” Licensed therapists are more than capable of supervising home health aides for
Activity of Daily Living care as well as in the carrying out of simple Home Exercise Programs. In
fact ADL training is a core teaching in both physical therapy and occupational therapy
curriculums, and most states allow for this supervision to occur. By allowing therapists to also
carry out home health aide supervisions, it will free up additional nursing resources to
accomplish DSRIP projects.
Response to Waiver Request:
No waiver needed. Federal CFR 484.3(d) requires that a patient receiving skilled
nursing care requires onsite supervision of the aide every 14 days, performed by a R.N. If the
patient is not receiving skilled nursing care, but is receiving another skilled service (PT, OT or
SLP), supervision may be provided by the appropriate therapist. Under 763.4, if the therapist is
the "professional" supervising the aide (for therapy-only cases), the therapist would supervise all
care provided by the aide, including assistance with Activity of Daily Living care.
15
Millennium Collaborative Care
and Treatment Centers / Urgent Care
Section 710.1 General provisions. Diagnostic
2.b.iii
Background and Justification submitted with your request:
Current regulatory requirements create an unfair competitive environment by requiring
Article 28 facilities to go through the CON progress when non-article 28 private practice groups
can establish/construction DTC without DOH involvement.
Response to Waiver Request:
Public Need and Financial Feasibility. Approved. The PPS requested waivers of 10
NYCRR 670.1, 709 and 710.2, with respect to the public need and financial feasibility
components of the CON process. Waivers are approved, however, note that:


No waiver is available for establishment applications.
Only the public need and financial feasibility component of the CON process is
waived, meaning that a construction application still need to be filed through
NYSE-CON and provider compliance will still be reviewed.
7  No waiver is available for specialized services, CHHA service area expansions,
and hospital and NH bed increases, which will be determined on a case-by-case
basis
16
Millennium Collaborative Care
Section 406.1 Definition.
2.a.i
Background and Justification submitted with your request:
For purposes of this section, a swing bed program operated by a rural hospital that has
an approval from the Health Care Financing Administration (HCFA) to provide post hospital
skilled nursing facility (SNF) care, shall mean beds used interchangeably as either general
hospital or nursing home beds with reimbursement based on the specific type of care provided
so that use of beds in this manner provides small hospitals with greater flexibility in meeting
fluctuating demands for inpatient general hospital and nursing home care. To allow small (<100
bed) urban Article 28 facilities to operate Swing Beds. To avoid emergency requests to local
offices for temporary permission to convert beds for volume surges.
Response to Waiver Request:
Denied. This is a federal requirement which we do not have the authority to waive.
17
Millennium Collaborative Care
712-1.7 Psychiatric units.
3.a.ii
Background and Justification submitted with your request:
The psychiatric unit, if included in a hospital as a separate nursing unit, shall have its
program requirements approved by the Commissioner of the Department of Mental Hygiene. To
relax the regulations required to establish new inpatient psychiatric specialty units (i.e:
geriopsych). Many national behavioral health agencies with expertise in managing inpatient
behavioral health units are unwilling to work with NYS Article 28 facilities due to the strict and
cumbersome regulatory requirements that must be followed.
Response to Waiver Request:
More Information needed. (OMH.) Please e-mail additional clarification to Keith
McCarthy of OMH at Keith.McCarthy@omh.ny.gov
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Millennium Collaborative Care
2.a.i
709.3 Residential health care facility beds.
Background and Justification submitted with your request:
Allow for a new category of RHCF pediatric beds at Highpointe: Pediatric Sub-Acute
Long Term Care. These beds would allow Article 28 SNFs to care for pediatric patients with a
combination of sub-acute and behavioral needs that no longer require an acute care hospital but
are also not appropriate for psychiatric facilities. Currently, no such services are available in
NYS and pediatric patients requiring such care are transferred out of state to facilities with
limited capacity and long wait-lists.
8 Response to Waiver Request:
Waiver not needed. 10 NYCRR 709.3 is nursing home bed need methodology. It does
not apply to pediatric nursing home beds. Pediatric units already receive specialty rates, which
embrace the entire gamut of care rendered in the pediatric unit, including ventilator-dependent
care and special medical, rehabilitative and educational needs for this population. The current
system is addressing the needs of this population, including the most complex children, who will
require a long nursing home stay, as well as children who require mainly rehabilitation prior to
discharge to home.
19
Millennium Collaborative Care
10 NYCRR 401.1: 10 NYCRR 401.2(b)
2.b.viii
Background and Justification submitted with your request:
NFMMC seeks waiver authority to permit employed physicians and mid-levels to provide
services outside of a certified service site and to be able to bill and receive reimbursement for
the provision of primary care services at patient homes. In March 2015, the New York State
Department of Health approved a waiver request from MCC to allow practitioners affiliated with
Article 28 providers to provide services outside of the certified service site.
While the request was approved, the State indicated that reimbursement for the
provision of such services would not be available absent approval of a State Plan Amendment
to the State Medicaid Plan and revisions to associated state regulations. The Department of
Health further indicated that it was pursuing necessary actions to permit the receipt of such
reimbursement. MCC is called upon to refile a waiver request to enable Article 28 providers to
conduct home visits. Such action will underscore the importance of permitting Article 28
providers to bill for such services.
NFMMC will be participating in the Hospital Home Care Collaboration project. To keep
home care patients out of the ED and to avoid unnecessary admissions, visits to home care
patients will be necessary to review medication regimens, conduct physical exams and retool
the patient’s at-home treatment plan. Without the ability to conduct and receive reimbursement
for such home visits it will be difficult to fully advance the objectives of the Hospital Home Care
Collaboration project.
Response to Waiver Request:
Off-Site Services or Home Visits. Approved. The PPS requested waivers of 10
NYCRR 401.2(b) for the purpose of allowing practitioners affiliated with Article 28 providers to
provide services outside of the certified service site. The request is approved, contingent upon
notification by the PPS of the specific providers, practitioners and services. However,
reimbursement for the provision of such services would not be available absent approval of a
State Plan Amendment (SPA) to the State Medicaid Plan and associated state regulations, both
of which are being pursued by the Department.
In cases where waivers are approved, the agencies will send letters directed to the
providers, who otherwise would be responsible for complying with the regulatory provisions at
issue. Further, providers will be advised that agency staff who conduct surveillance activities
9 will be notified that these regulatory waivers have been approved; however, they should
maintain a copy of their waiver letters at any site subject to surveillance.
Please note that the Department will publish on its website a list of regulatory waivers
that have been approved to assist PPSs in determining whether additional waivers may be
appropriate for the activities within a PPS. Additional requests for waivers, as well as any
questions regarding the foregoing, may be sent by e-mail to DSRIP@health.ny.gov with
Regulatory Waiver in the subject line.
Thank you for your cooperation with this initiative. We look forward to working with you
to transform New York’s delivery system.
Sincerely,
Howard A. Zucker, M.D., J.D.
Commissioner
New York State Department of Health
Ann Marie T. Sullivan, M.D.
Commissioner
New York State Office of Mental Health
Arlene González-Sánchez
Commissioner
New York State Office of Alcoholism
And Substance Abuse Services
10